Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency - a Double-blinded, Randomized and Placebo-controlled Intervention Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Chair-stand test
研究概览
简要总结
The purpose of this study is to increase the functional level of the elderly to thereby reduce fall risk, improve motor skills, and increase psychological well-being, as well as to assess whether the restoration of a normal testosterone level contributes to a faster recovery. The effect of testosterone is investigated as measured by physical and mental functional capacity, including cognition, in hypogonadal elderly men with a significant loss of function. The study is aimed at participants who are too weak to participate in the progressive strength training.
详细描述
Please see the uploaded study protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Treatment with testosterone is made double-blind. We will ensure that the persons evaluating a patient do not have knowledge of the patient's treatment group.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 70 or over.
- •Living at home in their own home or in sheltered housing.
- •Independent walking function, possibly with a walking aid.
- •Able to perform the chair-stand test a maximum of 8 times in 30 seconds or Timed Up and Go (TUG) of at least 30 seconds.
- •There must be at least 3 symptoms of frailty or objective findings.
- •Serum testosterone < 10 nmol/L as an average of 2 independent measurements at the Center for Growth and Reproduction, Rigshospitalet.
排除标准
- •Known or previous prostate cancer.
- •Abnormally elevated serum PSA (PSA = prostate-specific antigen) corresponding to PSA > 5 ng/ml or PSA > 0.15 ng/ml/cc (relative to prostate size in cubic centimeters (cc)).
- •Hemochromatosis.
- •Heart diseases in the form of: Peri-, myo-, or endocarditis, angina pectoris, severe heart failure (NYHA class III and IV), severe hypertension (systolic BP > 180 or diastolic BP > 105 mmHg after possible antihypertensive treatment). - Resting dyspnea.
- •Liver (ASAT > 2 x upper normal limit) or renal insufficiency (serum creatinine > 200 micromol/l).
- •Severe intractable epilepsy or migraine.
- •Insulin treatment.
- •Previous or current bisphosphonate, fluoride, HRT, SERM, strontium, teriparatide, or more than 3 weeks of prednisolone treatment.
- •Joint disease with acute inflammation.
- •Active cancer disease, in chemo- or radiotherapy.
- •Bone metabolic disease except for age-related osteoporosis.
- •Autoimmune diseases, chronic systemic diseases (cirrhosis, AIDS, chronic renal failure).
- •Primary testosterone deficiency in the form of testicular dysgenesis, Klinefelter syndrome (47,XXY), 46,XX males, LH resistance, Y chromosome deletions, other sex chromosome abnormalities.
- •Significant abuse, mental illness, dementia, physical handicaps with inability to complete the intervention or tests, or to give informed consent.
- •Contraindications for testosterone undecanoate are thus included in exclusion criteria, such as the presence of liver tumors, breast carcinoma, and prostate cancer, for which trial participants will be examined before the start of the trial.
研究组 & 干预措施
Placebo
Patients receiving placebo
Intervention
Patients receiving testosterone undecanoate
干预措施: Nebido (Testosterone Undecanoate) (Drug)
结局指标
主要结局
Chair-stand test
时间窗: At weeks 0, 4 and 20.
A measure of general strength in extremities. Number of times the participant can stand up and sit down from a chair in 30 seconds. A good correlation (r=0.78) has been found with leg press and acceptable test-retest reliability (ICC=0.86). It has recently been scientifically documented that the ability among elderly persons to perform this simple test correlates with the risk of serious fall accidents
次要结局
- Measurement of fall frequency and severity(At weeks 0, 4 and 20.)
- Balance ability(At weeks 0, 4 and 20.)
- Falls Efficacy Scale - International (FES-I, Fear of falling)(At weeks 0, 4 and 20.)
- Avlund's mobility scale(At weeks 0, 4 and 20.)
- Geriatric Depression Scale (GDS)(At weeks 0, 4 and 20.)
- Montreal Cognitive Assessment (MoCA)(At weeks 0, 4 and 20.)
- Mini Mental State Examination (MMSE)(At weeks 0, 4 and 20.)
- Quality of life EQ-5D(At weeks 0, 4 and 20.)
- Clinical Frailty Scale (CFS)(At weeks 0, 4 and 20.)
- Falls Efficacy Scale - International (FES-I, Fear of falling). Scores range from 16 to 64, and higher scores indicate increased anxiety of having a severe fall accident.(At weeks 0, 4 and 20.)
研究者
Rune Skovgaard Rasmussen
MSc, PhD, associate professor of general pathology
University Hospital, Gentofte, Copenhagen